MAUDE Adverse Event Report: VERATHON MEDICAL ULC GLIDESCOPE GVL SINGLE USE STAT; LARYNGOSCOPE, RIGID, PRODUCT CODE

Model Number 0270-0626

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the glidescope gvl single use stat that was used during the event was disposed of and would not be returned to verathon for evaluation; however, a photograph of the stat was provided and the damage was confirmed.The customer reviewed their current inventory of stats and found that there was one additional stat that was damaged in a similar manner.The additional stat was forwarded to verathon for further evaluation.A verathon technical service representative evaluated the returned stat where they were able to verify the reported issue.It was found that the tip of the stat was broken.The returned stat was forwarded to the contract manufacturer for additional investigation.

Event Description

The customer reported that during a patient procedure, using a gvl stat size 3, the tip of the stat broke off.The end user noted that the broken piece of the stat remained connected to the rest of the unit once removed.The procedure was completed using the reported stat with no delay noted.No harm to the patient or user reported.

• Brand Name: GLIDESCOPE GVL SINGLE USE STAT
• Type of Device: LARYNGOSCOPE, RIGID, PRODUCT CODE
• Manufacturer (Section D): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, V5C 5 A9; CA V5C 5A9
• Manufacturer (Section G): VERATHON MEDICAL ULC; 2227 douglas road; burnaby, V5C 5 A9; CA V5C 5A9
• Manufacturer Contact: corey kasbohm ; 20001 n creek pkwy; bothell, WA 98011-8218 ; 4256295760
• MDR Report Key: 8949716
• MDR Text Key: 158702768
• Report Number: 9615393-2019-00114
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0270-0626
• Device Catalogue Number: 0270-0626
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1